Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT00030693
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed metastatic unresectable solid tumors
* Cutaneous, subcutaneous, lymph node, or visceral tumors that are accessible to imaging and injections
* No standard therapy available
* At least 1 unidimensionally measurable lesion
* At least 20 mm for visceral lesions
* At least 10 mm for cutaneous, subcutaneous, and nodal lesions
* No untreated or edematous metastatic brain lesions
* At least 6 weeks since prior surgery and/or radiotherapy for brain metastases and no evidence of disease or edema on CT scan or MRI
* No ascites or pleural effusions
* No leptomeningeal disease
* Performance status - ECOG 0-1
* More than 3 months
* Absolute granulocyte count at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
* No bleeding diathesis
* Bilirubin no greater than 1.5 mg/dL\*
* SGOT/SGPT no greater than 2 times upper limit of normal (ULN)\*
* Alkaline phosphatase no greater than 2 times ULN\*
* No elevated PT or PTT
* No cirrhosis
* No active hepatitis
* No hepatic insufficiency
* Creatinine no greater than 2.0 mg/dL
* No renal insufficiency
* No chronic obstructive pulmonary disorder
* No active autoimmune disorders
* No active immunologically mediated disease (e.g., severe psoriasis, colitis, idiopathic thrombocytopenic purpura, multiple sclerosis, connective tissue disease, or active rheumatoid arthritis)
* No significant allergy or hypersensitivity to eggs
* No active seizure disorder
* No active or chronic infections
* No other significant medical disease that would preclude study participation
* No other malignancy within the past 5 years except stage I cervical cancer or basal cell carcinoma
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* More than 8 weeks since prior immunotherapy and recovered
* More than 4 weeks since prior chemotherapy and recovered
* At least 4 weeks since prior systemic corticosteroids
* No concurrent corticosteroids
* More than 2 weeks since prior radiotherapy and recovered
* No evidence of bone marrow toxicity from prior radiotherapy
* More than 4 weeks since prior surgery and recovered
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00030693
Study Brief:
Protocol Section:
NCT00030693